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Dockets Management

Dockets Entered On July 3, 2007
Docket # Title
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
2004P-0448 DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
2005N-0272 Irradiation in the Production, Processing & Handling of Food
2005P-0207 Change in Classification for Sonomet Body Composition Analyzer, BOD POD and PEAPOD
2005P-0213 To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
2005P-0406 Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration
2006P-0071 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
2006P-0245 Exclusivity Determination for Risperidone
2007D-0233 Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
2007D-0234 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
2007P-0003 Issue guidelines on Risk-Based Bioequivalence Testing
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
N 9 FDA Vol #: 10
2004P-0448 DERMA-SMOORHE/FS(fluocinolone acetonide 0.01% topical oil)
LET 3 FDA/HFD-7 to Hill Dermaceuticals, Inc. Vol #: 1
LET 4 FDA/DDM to Hill Dermaceuticals, Inc. Vol #: 1
2005N-0272 Irradiation in the Production, Processing & Handling of Food
C 153 V. Ferriero Vol #: 8
C 154 J. Sywak Vol #: 8
C 155 K. Smith Vol #: 8
C 156 J. M. Feist Vol #: 8
C 157 M. Hartsfield Vol #: 8
C 158 A. Rudlaff Vol #: 8
C 159 G. Gundlach Vol #: 8
C 160 J. Malone Vol #: 8
C 161 S. Akers Vol #: 8
C 162 R. Hensley & S. Hensley Vol #: 8
C 163 R. Bosch Vol #: 8
C 164 M. Sharp Vol #: 8
C 165 C. Schooley Vol #: 8
C 166 S. Carlstedt Vol #: 8
C 167 D. Owens Vol #: 8
C 168 R. Moldover Vol #: 8
C 169 A. Rawls Vol #: 8
C 170 M. Kirchenbauer Vol #: 8
C 171 N. Versakos Vol #: 8
C 172 S. J. Miller Vol #: 8
C 173 A. Shay Vol #: 8
C 174 R. Reynolds Vol #: 8
C 175 B. Steere Vol #: 8
C 176 H. Mcconnell Vol #: 8
C 177 E. Schoeppe Vol #: 8
C 178 D. Joseph Vol #: 8
C 179 S. Athelli Vol #: 8
C 180 E. Garcia Vol #: 8
C 181 S. Powell Vol #: 8
C 182 M. Agnew Vol #: 8
C 183 C. Green Vol #: 8
C 184 N. Spears Vol #: 8
C 185 P. Mcadoo Vol #: 8
C 186 N. Rick Vol #: 8
C 187 C. White Vol #: 8
C 188 M. Robatto Vol #: 8
C 189 T. Meyer Vol #: 8
C 190 N. Holter Vol #: 8
C 191 R. Nester Vol #: 8
C 192 C. Cartwright Vol #: 8
C 193 K. Knight Vol #: 8
C 194 Healthy Food Vol #: 8
C 195 R. Periano Vol #: 8
C 196 D. Rescinito Vol #: 8
C 197 P. Butt Vol #: 8
C 198 M. L. Morales Vol #: 8
C 199 L. Masters-lee Vol #: 8
C 200 T. Williams Vol #: 8
C 201 S. Gonzalez Vol #: 8
C 202 K. Montross Vol #: 8
C 203 S. Fisher Vol #: 8
C 204 S. Orum Vol #: 8
2005P-0207 Change in Classification for Sonomet Body Composition Analyzer, BOD POD and PEAPOD
ND 1 FDA Vol #: 2
2005P-0213 To change the classification of EEG electrodes currently classified as class II and requiring 510K approvals\
ND 1 FDA Vol #: 1
2005P-0406 Benzphetamine Hydrochloride Capsule, 50 mg drug product is suitable for submission as an ANDA
PAV 1 FDA/HFD-7 to Lachman Consultant Services, Inc Vol #: 1
2006D-0480 Guidance for Industry on Complementary & Alternative Medicine Products & Their Regulation by the Food and Drug Administration
EC 862 Mr. Chris Carthel Vol #: 26
EC 863 Mr. Brent Bialke Vol #: 26
EC 864 Myself Vol #: 26
EC 865 Mr. Ernest Brown Vol #: 26
EC 866 Mr. Robert Bocchichio Vol #: 26
EC 867 Consumer Vol #: 26
EC 868 Mr. Gerold Peters Vol #: 26
EC 869 Mr. Michael McCarthy Vol #: 26
EC 870 Mr. Vince Miraglia Vol #: 26
EC 871 Ms. Raven Cox Vol #: 26
EC 872 Mr. Paul Tungesvick Vol #: 26
EC 873 Helping You Vol #: 26
EC 874 Mr. Greg Guyer Vol #: 26
EC 875 Mr. Andrea Chirco Vol #: 26
EC 876 spectrum youth and family Vol #: 26
EC 877 Mrs. Virginia Brown Vol #: 26
EC 878 Mr. Ron philipps Vol #: 26
EC 879 Mt. Sinai Vol #: 26
EC 880 Miss. Zoe Lang Vol #: 26
EC 881 Dr. Harry Stafford Vol #: 26
EC 882 Mr. Walter Dawes Vol #: 26
EC 883 Ms. Roxie Hudak Vol #: 26
EC 884 Ms. Susan Brown Vol #: 26
EC 885 Mr. Kenneth Lewis Vol #: 26
EC 886 2006D-0480 Vol #: 26
EC 887 Mrs. Donna Bowlby Vol #: 26
EC 888 We The People Vol #: 26
EC 889 Dr. Anne Dunev Vol #: 26
EC 890 Mrs. Darlynn Cole Vol #: 26
EC 891 Mr. Robert Staker Vol #: 26
EC 892 Mrs. nancy terrell Vol #: 26
EC 893 Mr. steven garrison Vol #: 26
EC 894 Mrs. Billy Moss Vol #: 26
EC 895 Ms. Wendy Strgar Vol #: 26
EC 896 Miss. Leslie Dellaria Vol #: 26
EC 897 Young Living Distributor Vol #: 26
EC 898 Mr. Breck Bowers Vol #: 26
EC 899 Mrs. Jody Andrews Vol #: 26
EC 900 Mrs. Kathryn Mechling Vol #: 26
EC 901 none Vol #: 26
EC 902 Dr. Jonathan Cowan Vol #: 26
EC 903 Ms. Marcla Clarke Vol #: 26
EC 904 Mr. Wayne Hunt Vol #: 26
EC 905 EarthSave of the Lowcountry Vol #: 26
EC 906 Mrs. Susan Kraus Vol #: 26
EC 907 Ms. Sharrhan Williamson Vol #: 26
EC 908 Mrs. Miranda B Vol #: 26
EC 909 Mr. Greg Jones Vol #: 26
EC 910 Mr. Chris Lee Vol #: 26
EC 911 Dr. Harvey Utech Vol #: 26
EC 912 N/A Vol #: 26
EC 913 Mr. Lionel Thomas Vol #: 26
EC 914 Ms. barbara kitterman Vol #: 26
EC 915 Mr. Geoffrey Lott Vol #: 26
EC 916 Mr. vern iverson Vol #: 26
EC 917 Miss. Lydia Marshall Vol #: 26
EC 918 Ms. Becky Tarrant Vol #: 26
EC 919 Mr. larry dean Vol #: 26
EC 920 Ms. Cherry Ivey Vol #: 26
EC 921 Mrs. Sandra Gainsforth Vol #: 26
EC 922 Ms. Sylvia Massara Vol #: 26
EC 923 Mr. guy decker Vol #: 26
EC 924 Mr. Matt Stamas Vol #: 26
EC 925 Ms. Elizabeth Alex Vol #: 26
EC 926 Mrs. Dawn Moylan Vol #: 26
EC 927 N/A Vol #: 26
EC 928 Miss. Shannon Strecheniuk Vol #: 26
EC 929 Ms. Mamak Cocks Vol #: 26
EC 930 Ms. Elizabeth Grant Vol #: 26
EC 931 Mr. Grant Miller Vol #: 26
EC 932 Dr. Karla Thaler Vol #: 26
EC 933 Ms. Marion Hochberg Vol #: 26
EC 934 Mr. Stuart Elliott Vol #: 26
EC 935 My Own Health Vol #: 26
EC 936 Ms. olivia laField Vol #: 26
EC 937 Mr. Bill Jones Vol #: 26
EC 938 St Helena Unified School District Vol #: 26
EC 939 Ms. Emily Heinecke Vol #: 26
EC 940 Ms. Roni Bergerson Vol #: 26
EC 941 Ms. deborah focht Vol #: 26
EC 942 Mr. Liam Bergerson Vol #: 26
EC 943 Mr. John Smith Vol #: 26
EC 944 Mr. Menging Tang Vol #: 26
EC 945 Ms. Linda Manuel Vol #: 26
EC 946 Dr. Marv Graham Vol #: 26
EC 947 Ms. carole bucher Vol #: 26
EC 948 Mr. John Downing Vol #: 26
EC 949 Ms. Dianne ODell Vol #: 26
EC 950 Ms. Royce Morales Vol #: 26
EC 951 Ms. Jean Jenkins Vol #: 26
EC 952 Mr. Navin Chetram Vol #: 26
EC 953 Mr. Kenneth Pearlman Vol #: 26
EC 954 Mr. Ronald Arboleda Vol #: 26
EC 955 Mrs. Janet Swift Vol #: 26
EC 956 Mrs. Tishia Chambers Vol #: 26
EC 957 Dr. JA Milburn Vol #: 26
EC 958 Ms. Jamie Pullos Vol #: 26
EC 959 Mr. Ron Fein Vol #: 26
EC 960 Mr. Jim Paulson Vol #: 26
EC 961 Mr. Michael Frost Vol #: 26
EC 962 Mrs. Kim Bucci Vol #: 26
EC 963 Ms. Roberta Horn Vol #: 26
EC 964 Mr. George Smith Vol #: 26
EC 965 Ms. janice palma-glennie Vol #: 26
EC 966 Ms. VIVIAN KUBRICK Vol #: 26
EC 967 Mrs. Gina Van Luven Vol #: 26
EC 968 Mrs. Jeannine Vigen Vol #: 26
EC 969 Mr. David Williams Vol #: 26
EC 970 Ms. Rita Rosario Vol #: 26
EC 971 Mr. Matthew Stewart Vol #: 26
EC 972 Mr. Stephen Mann Vol #: 26
EC 973 Miss. Kay Gore Vol #: 26
EC 974 Ms. Lisa Siciliani Vol #: 26
EC 975 Mrs. Amy Lively Vol #: 26
EC 976 Mr. Phillip Bruemmer Vol #: 26
EC 977 Mrs. christine moss Vol #: 26
EC 978 Mr. Ryan Kiel Vol #: 26
EC 979 Integrate Healing Vol #: 26
EC 980 Mr. Alban Beete Vol #: 26
EC 981 none Vol #: 26
EC 982 Mr. Stephen Lowy Vol #: 26
EC 983 Mr. Paul Devlin Vol #: 26
EC 984 Mr. Paul Dacko Vol #: 26
EC 985 Mr. zemach wilson Vol #: 26
EC 986 Ms. Deborah Smith Vol #: 26
EC 987 Mr. Kenn Ward Vol #: 26
EC 988 Ms. Billie Powell Vol #: 26
EC 989 Mr. Chris Jones Vol #: 26
EC 990 Mr. Terry Young Vol #: 26
EC 991 Mrs. Ruth Dyhr Vol #: 26
EC 992 Mrs. Lori Saxman Vol #: 26
EC 993 Mrs. Ginger Von Dinkel Vol #: 26
EC 994 Ms. Juanita Norval Vol #: 26
EC 995 Mrs. Laurie Hale Vol #: 26
EC 996 Ms. Ann Ann Vol #: 26
EC 997 Mrs. Linda Yates Vol #: 26
EC 998 Ms. Cam Trinh Vol #: 26
EC 999 Mrs. Amy Hudelson Vol #: 26
EC 1000 Miss. Heidi Groth Vol #: 26
EC 1001 Homeopathic doctor's practice Vol #: 26
EC 1002 Mr. Joseph Dollan Vol #: 26
EC 1003 Learning Unlimited Vol #: 26
EC 1004 Mr. Anson Chong Vol #: 27
EC 1005 Mrs. CINDY GAINSFORTH Vol #: 27
EC 1006 Mr. Miles H Mulcahy Vol #: 27
EC 1007 Mr. Richard Butz Vol #: 27
EC 1008 Mrs. cindy lake Vol #: 27
EC 1009 Mr. Kyle Castleberry Vol #: 27
EC 1010 Dr. Gregory Combs Vol #: 27
EC 1011 Mr. al vanderford Vol #: 27
EC 1012 Ms. Sara Altshul Vol #: 27
EC 1013 Mr. Pedro Aleman Vol #: 27
EC 1014 Ms. kerry searle Vol #: 27
EC 1015 Mr. Denis Sanchez Vol #: 27
EC 1016 Mr. Michael Gavitt Vol #: 27
EC 1017 Mr. Haraldur Magnysson Vol #: 27
EC 1018 Mr. Robert Aaron Vol #: 27
EC 1019 Mr. Alan Beer Vol #: 27
EC 1020 Mrs. j mesa Vol #: 27
EC 1021 Mrs. Kelley Loveless Vol #: 27
EC 1022 Private Citizen, Consumer, Voter Vol #: 27
EC 1023 Mrs. Linda Harmon Vol #: 27
EC 1024 Miss. clare russell Vol #: 27
EC 1025 Miss. Rachel Smith Vol #: 27
EC 1026 Mr. Hongdau Liu Vol #: 27
EC 1027 Ms. Marjorie Erway Vol #: 27
EC 1028 Mrs. April Nilsson Vol #: 27
EC 1029 Mrs. Athene Anderson Vol #: 27
EC 1030 private citizen Vol #: 27
EC 1031 Ms. Kiley Larson Vol #: 27
EC 1032 Ms. MARGARET AYHAN Vol #: 27
EC 1033 Mr. Brian Tierney Vol #: 27
EC 1034 Mrs. johanna vrielink Vol #: 27
EC 1035 Mr. Jon Tore Lande Vol #: 27
EC 1036 Ms. Janice Fevang-Hill Vol #: 27
EC 1037 Ms. Christi Ballard Vol #: 27
EC 1038 Dr. Tim Stahl Vol #: 27
EC 1039 Ms. nancy walker Vol #: 27
EC 1040 Mr. Rick Walker Vol #: 27
EC 1041 Dr. Channon MOON Vol #: 27
EC 1042 Mr. Robert Rock Vol #: 27
EC 1043 Dr. Gail Combs Vol #: 27
EC 1044 Mr. ROBERT JENCKS Vol #: 27
EC 1045 Children's Hospital Vol #: 27
EC 1046 Ms. Esther Sutter Vol #: 27
EC 1047 Ms. Linda Summers Vol #: 27
EC 1048 Mr. M. Todd Lassich Vol #: 27
EC 1049 Mr. bob browning Vol #: 27
EC 1050 Ms. Karen Smith Vol #: 27
EC 1051 Mrs. Rose Overcash Vol #: 27
EC 1052 Mr. Ville Sarell Vol #: 27
EC 1053 Ms. Linda Summers Vol #: 27
EC 1054 Ms. JUDIE virzi Vol #: 27
EC 1055 Mr. Steven Sprengel Vol #: 27
EC 1056 Mr. Michael Hulbert Vol #: 27
EC 1057 Mr. Eugene Richter Vol #: 27
EC 1058 Mr. Jim Hix Vol #: 27
EC 1059 Mrs. Bobbie Allison Vol #: 27
EC 1060 Mrs. Charlotte Berglund Vol #: 27
EC 1061 Ozone Energy Solutions Vol #: 27
EC 1062 Mr. Don Bahn Vol #: 27
EC 1063 Disabled/ Retired Vol #: 27
EC 1064 Mrs. kathleen Boutin Vol #: 27
EC 1065 Ms. Janet Kitsmiller Vol #: 27
EC 1066 Mr. John Giordano Vol #: 27
EC 1067 Mr. Dan Aardema Vol #: 27
EC 1068 Mr. Andrew Havens Vol #: 27
EC 1069 Ms. Susan Gillispie Vol #: 27
EC 1070 Mr. Dixon Marin Vol #: 27
EC 1071 Mrs. Suzanne VaughnBatiz Vol #: 27
EC 1072 Ms. Marilyn Teberio Vol #: 27
EC 1073 Mr. Jeffery Porter Vol #: 27
EC 1074 Registered Dietitian Vol #: 27
EC 1075 Ms. Stephanie Frazier Vol #: 27
2006P-0071 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
NPR 1 FDA Vol #: 2
2006P-0245 Exclusivity Determination for Risperidone
WDL 1 Mylan Pharmaceuticals Inc. Vol #: 1
2007D-0233 Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007D-0234 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
2007P-0003 Issue guidelines on Risk-Based Bioequivalence Testing
LET 1 FDA/HFD-7 to Pharmaceutical Scientist, Inc. Vol #: 1
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
EC 851 Ms. Nina Ann Tanabe Vol #: 11
EC 852 Miss. Zoe Smith Vol #: 11
EC 853 Don't Mess With Our Chocolate Vol #: 11
EC 854 Mrs. Elizabeth Lendall Vol #: 11
EC 855 Mr. Kenneth Rowe Vol #: 11
EC 856 Don't Mess With Our Chocolate Vol #: 11
EC 857 Don't Mess With Chocolate Vol #: 11
EC 858 Ms. Wendy Alexander Vol #: 11
EC 859 Mr. Ross Campbell Vol #: 11
EC 860 Mrs. Brenda Gornick Vol #: 11
EC 861 Mrs. Stacey Rabkin Vol #: 11
EC 862 Dr. Daniela Bell Vol #: 11
EC 863 Don't Mess With Chocolate Vol #: 11
EC 864 Andy's Handmade Chocolates Vol #: 11
EC 865 Ms. Lynne Kane Vol #: 11
EC 866 Mrs. Laurie Donaldson Vol #: 11
EC 867 Ms. Eli Penberthy Vol #: 11
EC 868 Mrs. Brit Penberthy Vol #: 11
EC 869 Mr. Philip Penberthy Vol #: 11
EC 870 Mrs. Eli Sevenich Vol #: 11
EC 871 Ms. Hanna Penberthy Vol #: 11
EC 872 Mrs. Margret Rowland Vol #: 11
EC 873 Ms. Patty Gates Vol #: 11
EC 874 Mrs. Debra Watts Vol #: 11
EC 875 University of California, Irvine Vol #: 11
EC 876 Mrs. Rosemarie Shindel Vol #: 11
EC 877 Mrs. Shari Lepore Vol #: 11
EC 878 Ms. B.R. Freeman Vol #: 11
EC 879 Mrs. Joanna Huffman Vol #: 11
EC 880 Don't Mess With Our Chocolate!! Vol #: 11
EC 881 Don't mess with our chocolate Vol #: 11
EC 882 Not Applicable Vol #: 11
EC 883 MIT Vol #: 11
EC 884 Mrs. Alison Randolph-Page Vol #: 11
EC 885 Mr. Sean Chen Vol #: 11
EC 886 B.R.Guest inc Vol #: 11
EC 887 Ms. Jane Spratler Vol #: 11
EC 888 Mr. Thomas Keegan Vol #: 11
EC 889 Mr. lynn mcneely Vol #: 11
EC 890 Ms. leslie fazenbaker Vol #: 11
EC 891 Ms. Josiane Saltoun Vol #: 11
EC 892 Don't Mess With Our Chocolate Vol #: 11
EC 893 Red monkey restaurant group Vol #: 11
EC 894 Ms. Suzie Hill Vol #: 11
EC 895 Don't Mess With Our Chocolate Vol #: 11
EC 896 Mr. Richard Kollins Vol #: 11
EC 897 Don't mess with chocolate Vol #: 11
EC 898 Mrs. Lisa Wantland Vol #: 11
EC 899 Ms. T. Nelson Vol #: 11
EC 900 Mrs. Peg Rounds Vol #: 11
EC 901 Don't Mess With Our Chocolate Vol #: 11
EC 902 Don't Mess With Our Chocolate Vol #: 11
EC 903 Chocolat Michel Cluizel Vol #: 11
EC 904 Don't Mess With Our Chocolate Vol #: 11
EC 905 Mr. Thomas Pittard Vol #: 11
EC 906 Mr. Frank Martin Vol #: 11
EC 907 Don't Mess With Our Chocolate Vol #: 11
EC 908 Ms. DeBorah Goletz Vol #: 11
EC 909 Ms. Nancy Benedict Vol #: 11
EC 910 Ms. Corie Ferguson Vol #: 11
EC 911 Mr. Zak Perez Vol #: 11
EC 912 Mrs. Fawcett Gloria Vol #: 11
EC 913 Ms. M.J. Olson Vol #: 11
EC 914 Don't Mess With Our Chocolate Vol #: 11
EC 915 Mrs. Sarah Bell Vol #: 11

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